On April 14, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported three abstracts were accepted for presentation at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held from Friday, April 14 – Wednesday, April 19 in Orlando, FL (Press release, Carisma Therapeutics, APR 14, 2023, View Source [SID1234630114]). The accepted data reinforce the potential of Carisma’s differentiated and proprietary cell therapy platform focused on engineered macrophages as a novel treatment pathway for hard-to-treat cancers and other serious illnesses.

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"The three abstracts being presented at the AACR (Free AACR Whitepaper) Annual Meeting reiterate our commitment to adding robust depth to our engineered macrophage platform," said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma Therapeutics. "As we continue to treat patients with HER2 overexpressing solid tumors in the clinic with our lead program CT-0508, we are excited to present on two of our pre-clinical programs that represent advancements in macrophage-based cell therapy. We believe that our mesothelin program has the potential to bring CAR-M therapy to patients with a variety of mesothelin positive solid tumors, and that our novel engineered microenvironment converter (EM-C) platform has the potential to reverse immunosuppression in the solid tumor and, conversely, reverse inflammation in auto-immune disease."

Accepted for AACR (Free AACR Whitepaper) presentation is, "A phase 1, first-in-human (FIH) study of autologous anti-HER2 chimeric antigen receptor macrophage (CAR-M) in participants (pt) with HER2 overexpressing solid tumors," to be presented by Yara Abdou, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center. This Trials-In-Progress poster provides an overview of the phase 1 FIH study design, objectives, and eligibility criteria, that is evaluating safety, tolerability, cell manufacturing feasibility, trafficking, tumor microenvironment (TME) activation, and preliminary evidence of efficacy of CT-0508 in participants with locally advanced metastatic solid tumors overexpressing HER2.

In the poster presentation, "Macrophages engineered with cytokine switch receptors: Development of a modular platform for rebalancing inflammation in microenvironments," to be presented by Chris Sloas, PhD, Senior Scientist at Carisma, Carisma is presenting a novel immunotherapy platform that harnesses macrophages as "living converters" to locally regulate inflammation for oncology and inflammatory applications. The study demonstrates that this platform offers modularity in controlling the inflammatory status of tissue microenvironments without systemic cytokine antagonism and represents a major advance in macrophage-base cell therapy.

Carisma will also share key findings from recent studies including, "A mesothelin targeting chimeric antigen receptor macrophage (CAR-M) for solid tumor immunotherapy: pre-clinical development of CT-1119," to be presented by Nicholas Anderson, PhD, Principal Scientist at Carisma. The study demonstrated that CT-1119, an autologous human anti-mesothelin chimeric antigen receptor macrophage (CAR-M), can phagocytose, eradicate, and induce an inflammatory response against mesothelin overexpressing solid tumors. These results show that CAR-M is a feasible approach for the treatment of mesothelin overexpressing solid tumors.

The following poster presentations will be published on the AACR (Free AACR Whitepaper) Annual Meeting website and available for registered attendees during the dates/times indicated below:

Tuesday, April 18 at 9:00 am ET: Macrophages engineered with cytokine switch receptors: Development of a modular platform for rebalancing inflammation in microenvironments

Tuesday, April 18 at 9:00 am ET: A mesothelin targeting chimeric antigen receptor macrophage (CAR-M) for solid tumor immunotherapy: pre-clinical development of CT-1119

Tuesday, April 18 at 1:30 pm ET-5:00 pm ET: A phase 1, first-in-human (FIH) study of autologous anti-HER2 chimeric antigen receptor macrophage (CAR-M) in participants (pt) with HER2 overexpressing solid tumors

About CT-0508
CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma Therapeutics is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for its CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at five U.S. sites, including Abramson Cancer Center at The University of Pennsylvania; the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill; City of Hope in Duarte, California; University of Texas MD Anderson Cancer Center in Houston, Texas; and Sarah Cannon Research Institute at Tennessee Oncology – Nashville.

On April 14, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported the presentation of two late-breaking research posters during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, 2023, in Orlando, Florida (Press release, Sapience Therapeutics, APR 14, 2023, View Source [SID1234630113]).

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"We are thrilled to showcase late-breaking results at this year’s AACR (Free AACR Whitepaper) meeting with data from our ST101 and ST316 programs that address difficult-to-drug cancer targets, C/EBPβ and β-catenin," said Dr. Barry Kappel, founder, CEO and President of Sapience. "These datasets demonstrate the roles of ST101 and ST316 in shifting an immune-suppressive tumor microenvironment to an immune-active state, and support evaluating both agents in coordination with immune-oncology (I/O) therapeutic strategies. In particular, with ST316 set to begin patient dosing in a Phase 1-2 clinical study in mid-2023, we are excited that these datasets further elucidate its unique mechanism of action."

ST101 Abstract Highlights:

ST101 is a first-in-class antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in advanced solid tumors. ST101 is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279).

As a critical regulator of the immunosuppressive tumor microenvironment, activation of C/EBPβ triggers macrophage polarization toward immunosuppressive M2-type myeloid-derived suppressor cells (MDSCs) and correlates with poor prognosis in several types of human cancer.
ST101 reprograms tumor-associated macrophages (TAMs) from the M2 phenotype toward the immune-promoting M1 phenotype, representing an attractive strategy to enhance antitumor immunity.
In preclinical models, ST101-mediated macrophage polarization to the M1 phenotype enhances the in vivo anti-tumor activity of anti-PD1 checkpoint inhibition.
In patient biopsies, ST101 modulates the tumor immune microenvironment by suppressing genes required for M2 macrophage polarization, culminating in an enhanced CD8 T-cell/Treg ratio.
The data support a novel, macrophage-driven mechanism of action for ST101 and suggest the exploration of ST101 in I/O therapeutic strategies.
Title: "ST101, a peptide antagonist of novel I/O target C/EBPβ, reprograms MDSCs and promotes an immunoactive tumor microenvironment"
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date and Time: Tuesday April 18, 2023, 1:30 PM – 5:00 PM
Location: Poster Section 34
Abstract Presentation Number: LB236

ST316 Abstract Highlights:

ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator BCL9, a complex that drives oncogenesis in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. In March of this year, Sapience announced that it received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1-2 clinical trial of ST316 for the treatment of solid tumors.

In addition to its direct oncogenic role, dysregulated Wnt/b-catenin signaling also promotes tumorigenesis by suppressing the tumor immune microenvironment (TIME).
Nonclinical data indicate that ST316 exposure to human peripheral blood mononuclear cells shifts M2 macrophages to the M1 phenotype and increases CD8 T-cell activation in macrophage/T-cell mixed cultures.
ST316 enhances the anti-tumor activity of anti-PD-1 checkpoint inhibition in a preclinical triple-negative breast cancer model.
These results support the immuno-therapeutic potential of ST316 to enhance current I/O therapeutic approaches.
Title: "Immunotherapeutic potential of ST316, a peptide antagonist of β-catenin"
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1
Session Date and Time: Sunday April 16, 2023, 1:30 PM – 5:00 PM
Location: Poster Section 35
Abstract Presentation Number: LB016

Abstracts and full session details are available through the AACR (Free AACR Whitepaper) Annual Meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2023 | Meetings | AACR (Free AACR Whitepaper)

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is evaluating patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for Stage IIb-IV melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

About ST316

ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator BCL9, a complex that drives oncogene expression in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. The interaction between β-catenin and BCL9 has previously been considered an ‘undruggable’ target due to the inability of small molecules to inhibit complex formation and antibodies to gain access to the cytoplasm or nucleus to disrupt the interaction. ST316 contains a cell penetration moiety to allow intracellular access and a domain designed to bind the first armadillo repeat domain of β-catenin, a site utilized by BCL9 but no other β-catenin binding partners. ST316 suppresses transcription of oncogenic Wnt target genes regulating proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes regulating the immunosuppression of the tumor microenvironment.

Sapience has received IND clearance to proceed with a Phase 1-2 clinical study of ST316. The Phase 1 dose-escalation portion of the study is designed as a basket study to enroll patients with tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway. Sapience expects to begin dosing patients in the Phase 1 portion in mid-2023 to evaluate the safety, clinical activity, pharmacokinetics and pharmacodynamics of ST316. The Phase 2 dose-expansion portion of the study will enroll patients in four specific tumor types known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including cholangiocarcinoma, colorectal, triple negative breast and ovarian cancers.

On April 14, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported the presentation of three posters at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper), taking place April 14-19, 2023, in Orlando, FL (Press release, Aadi Bioscience, APR 14, 2023, View Source [SID1234630112]).

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The presentations at AACR (Free AACR Whitepaper) 2023 include: a trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial, a registrational directed tumor agnostic study for patients with solid tumors driven by TSC1 or TSC2 alterations; results on the anti-tumor activity of nab-sirolimus in combination with KRAS-G12C inhibitors in xenograft models; and results of a biomarker analysis from the AMPECT trial correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations, which includes previously reported response data from AMPECT.

Abstracts and poster presentation details are below:

Title: "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2 (PRECISION I)"
Date and Time: Monday, April 17, 2023, 9:00 AM – 12:30 PM
Session Title: Phase II and Phase III Clinical Trials in Progress
Presentation Number: CT057

Abstract highlights:

nab-Sirolimus is a novel albumin-bound mTOR inhibitor (mTORi) approved in the US for adult patients with advanced malignant PEComa.
Eligible patients are ≥12 years old and mTORi-naïve, possess malignant solid tumors with TSC1 or TSC2 inactivating alterations (confirmed by central review of sequencing reports), and have received appropriate standard treatments, as determined by the investigator.
Available data from the AMPECT exploratory analysis and an expanded access program suggest acceptable efficacy and safety of nab-sirolimus, an mTORi with enhanced antitumor activity, in patients with solid tumors harboring inactivating alterations in TSC1 and/or TSC2.
nab-Sirolimus 100 mg/m2 will be given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate per independent radiographic review (IRR) using RECIST v1.1. Other endpoints include duration of response, time to response, progression-free survival by IRR, overall survival, patient-reported quality of life, and safety.
Enrollment began in March 2022. Collaboration with leading next-generation sequencing vendors will expedite the identification of patients with qualifying TSC1 or TSC2 mutations; study access will be facilitated through a "just-in-time" approach to trial location activation.
Based on the prevalence of TSC1 or TSC2 inactivating alterations, the most frequent tumor types expected are bladder, hepatobiliary, endometrial, soft tissue sarcoma, ovarian, and esophagogastric.
Title: "Synergistic anti-tumor activity of nab-sirolimus in combination with KRAS inhibitors (KRASis) sotorasib and adagrasib in KRAS G12C NSCLC and bladder cancer xenografts"
Date and Time: Tuesday, April 18, 2023, 1:30 – 5:00 PM
Session Category: Clinical Research Excluding Trials
Session Title: Combination Therapies for Cancer
Presentation Number: 5484

Abstract highlights:

KRAS is frequently mutated in non-small cell lung cancer (NSCLC) and other tumor types, with KRAS G12C mutation representing ~12% of patients with NSCLC. Sotorasib and adagrasib are approved for the treatment of KRAS­ G12C NSCLC. Mutations in KRAS may lead to mTORC1 activation, and mTOR may contribute to adaptive resistance to KRASis.
This study investigated the antitumor activity of nab-sirolimus in combination with KRASis in KRAS G12C NSCLC and bladder xenograft models.
nab-sirolimus in combination with either sotorasib or adagrasib showed greater tumor growth inhibition, a higher meaningful tumor regression rate and synergistic antitumor activity vs single agent therapy.
A multicenter, single-arm, open-label Phase 1/2 clinical study is planned to determine the recommended Phase 2 dose, safety, tolerability, and efficacy for the combination of adagrasib and nab-sirolimus in patients with KRAS G12C tumors.
Title: "Biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations"
Date and Time: Wednesday, April 19, 2023, 9:00 AM – 12:30 PM
Session Category: Clinical Research Excluding Trials
Session Title: Late-Breaking Research: Clinical Research 3
Presentation Number: LB288

Abstract Highlights:

An exploratory biomarker analysis was performed on samples from patients enrolled in the AMPECT study, a Phase 2, multicenter, open-label trial in advanced malignant PEComa (NCT02494570).
A variety of pathogenic inactivating alterations were observed in TSC1 and TSC2 genes, though TSC2 mutations were most commonly frameshift mutations; no recurring mutations were observed.
A tumor-agnostic study (PRECISION 1: NCT05103358) is now recruiting patients with pathogenic inactivating TSC1 or TSC2 alterations to further examine these biomarker findings.
Full session and meeting details are available through the AACR (Free AACR Whitepaper) Annual Meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2023 | Meetings | AACR (Free AACR Whitepaper). Each poster will be made available following the date of presentation at AACR (Free AACR Whitepaper), on the investor relations page of the Aadi website at www.aadibio.com

On April 14, 2023 Geneius Biotechnology, Inc., an immuno-oncology company developing a best-in-class personalized RNA-enabled T cell therapy platform that generates a robust immune response to solid and liquid cancers, reported that the company will present a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-19, 2023, in Orlando, Florida (Press release, Geneius Biotechnology, APR 14, 2023, View Source [SID1234630111]).

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The abstract will be available on the AACR (Free AACR Whitepaper) meeting website. The poster will be available online at www.geneiusbiotech.com following the presentation.

Poster Presentation Details

Abstract 4067 – RNA primed SMAR-T cells against multiple driver mutations, all HLA’s, designed for first line therapy
Date/Time: Tuesday, April 18, 2023, 9:00 AM – 12:30 PM ET
Session: Adoptive Cell and Natural Killer Cell Therapy
Presenter: Alfred E. Slanetz, Ph. D.
Location: Orange County Convention Center, Poster Section 22, Poster Board 19

About RNA primed SMAR-T cells

SMAR-T is an RNA-enabled T cell therapy targeting multiple driver mutations to extend immunotherapy to the 95% of solid tumor patients who currently don’t have an effective anti-PD1 immunotherapy. Anti-PD1 (Keytruda and Opdivo) provides great benefit to patients whose cancers have high mutational burden by recruiting new T cells from the blood into the tumor and unleashing those previously dormant T cells. Geneius’s treatments deliver a high dose of these cells, whose T cell receptors (TCRs) are "educated" using our proprietary RNA technology to create multiple TCRs recognizing multiple cancer driver mutations in the context of all HLA for the 95% of patients whose tumors have low of mutational burden. SMAR-T expands T cells reactive to multiple driver mutations from the blood with all of the T cell phenotypes for an ideal cancer therapy. The "ultimate TCR-T": SMAR-T uses the entire repertoire of T-cell receptors and HLA in a parallel system targeting multiple, specific cell-surface and internal driver mutations. However, unlike current TCR-T, SMAR-T works with every patient’s HLA, recognizes multiple peptides, is cost effective to manufacture and has no cross-reactivity.

SMAR-T cells kill tumor cells but not normal cells, needing only one amino acid difference to distinguish a cancer mutation from normal. In a single closed system production run, we produce SMAR-T to target greater than 20 driver mutations efficiently and cost effectively in a disposable bioreactor. T cells targeting multiple mutations prevent the cancer from "escaping" therapy by a cell not expressing a particular mutation and allows the T cell product to combat heterogenous solid tumors. Our key product is SMAR-T targeting solid tumors starting with Melanoma, Lung and Pancreatic cancer. We collaborate with Yale (CT) and Mount Sinai (NY/NJ) to conduct clinical trials and phase I manufacturing with clinical data anticipated in 2024.

On April 14, 2023 Biological Dynamics, a life sciences company focused on developing and commercializing exosome isolation technology for earlier disease detection, will present data showing how the company’s ExoVerita platform can be utilized for early detection of lung and pancreatic cancers at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Orlando, Fl., April 14-19 (Press release, Biological Dynamics, APR 14, 2023, View Source [SID1234630110]). A case study of early pancreatic cancer management will also be discussed at the meeting. Biological Dynamics’ will exhibit its technology and early cancer detection assays at booth #1368.

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"We are developing a clinical tool to enable early disease detection in order to improve patient survival outcomes for the most challenging cancers," said Harmeet Dhani, MD, MSc, Medical Director at Biological Dynamics. "Pancreatic and lung cancers are two of the deadliest cancers in the U.S., as they are often diagnosed in late stages, making treatment more difficult and lowering survival chances. Our data clearly demonstrate the ExoVerita platform, with its assay applications, can detect important cancers earlier than standard of care approaches using a new generation of biomarkers and technology. Surveillance of high cancer risk individuals with these new methods should proceed."

Two posters will be presented on April 19 from 9 am to 12:30 pm EDT, including:

"Pancreatic ductal adenocarcinoma (PDAC) early detection," which shows that in 105 pathologically confirmed PDAC cases (Stage 1 = 39; Stage II = 66) and 545 controls, the ExoVita Pancreas assay detected cancer at stages 1 and 2 with 93% sensitivity and 91% specificity. The assay is performed on the ExoVerita platform, which isolates and analyzes EVs, including exosomes found in patient blood samples.
"Liquid biopsy for lung cancer based on extracellular vesicles," presenting data from a pilot study evaluating 143 pathologically confirmed lung cancer cases and 491 controls using a stratified cross-validation approach. Results show that Biological Dynamics’ lung assay, performed on the ExoVerita platform, detected cancer with an overall sensitivity and specificity of approximately 91%.
The poster featuring a case study titled "Early detection of high-grade IPMN using extracellular vesicles – a successful patient story" will be presented on April 16 from 1:30 pm to 5 pm EDT. The case study highlights how the ExoVita Pancreas test (available as a laboratory developed test) can be used as part of a diagnostic workup to aid earlier detection of a high-grade precursor malignant lesion in a patient with acute pancreatitis and no radiographic evidence of lesions found on standard-of-care diagnostic imaging.

Biological Dynamics’ patented ExoVerita platform targets and isolates exosomes which carry informative biomarkers. Assays, like ExoVita, that run on the platform can detect specific, blood-based exosome protein biomarkers, enabling high-sensitivity detection of cancer in its early stages. The presented data suggest the potential for the company’s technology and assays to become an integral component of surveillance for and early detection of cancers.